A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

R

Response Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Metformin
Drug: SLx-4090
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871936
SLx-4090-09-07

Details and patient eligibility

About

The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

Full description

HbA1c after 12 weeks FPG after 12 weeks Safety and tolerability Plasma levels of SLx-4090

Enrollment

82 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HbA1c 7-11%
  • On a stable dose of metformin for at least 6 weeks

Exclusion criteria

  • Type 1 Diabetes
  • Antidiabetic medication other than or in addition to metformin
  • FPG > 270 mg/dL

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

1
Experimental group
Description:
SLx-4090 in combination with Metformin
Treatment:
Drug: SLx-4090
Drug: Metformin
2
Other group
Description:
Placebo
Treatment:
Other: Placebo
Drug: Metformin

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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